Actively Recruiting
Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer
Led by Tongji Hospital · Updated on 2026-01-08
651
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatocellular carcinoma (HCC) carries a poor prognosis, with limited efficacy from current therapies including immune checkpoint inhibitors (ICIs). Concurrently, emotional distress (ED) is highly prevalent in cancer patients and is implicated in tumor progression via neuroendocrine-immune axis dysregulation (e.g., HPA axis activation, immunosuppressive TME). Emerging evidence, particularly from lung cancer, suggests ED may adversely impact ICI efficacy. However, its specific role and clinical significance in HCC, especially regarding ICI response, remain poorly understood. To address this gap, we propose a large-scale, prospective, multicenter, multi-cohort study to systematically evaluate the impact of ED on treatment outcomes in HCC patients receiving immunotherapy.
CONDITIONS
Official Title
Impact of Emotional Disorders on Response to Immune Checkpoint Inhibitor Therapy in Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, inclusive, regardless of gender.
- Presence of at least one radiologically measurable lesion according to RECIST version 1.1 (lesion size 10 mm on CT scan).
- Newly diagnosed, treatment-naFve patients with hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC).
- Child-Pugh liver function score 7.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No severe organic diseases affecting heart, lungs, brain, or other major organs.
You will not qualify if you...
- History of other malignancies.
- Recurrent hepatocellular carcinoma.
- Prior systemic therapy for hepatocellular carcinoma.
- Hepatic decompensation.
- History of severe psychiatric disorders.
- Current use of antidepressant or anxiolytic medication.
- Inability to comprehend or complete assessment questionnaires.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
W
Wanguang Zhang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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